Guidance on IDE Benefit-Risk Determinations

FDA has released a final guidance on “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.” The document is intended to provide greater clarity on the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies. The agency believes that by improving clarity more medical device clinical trials will be conducted in the U.S. The document discusses how risk-benefit uncertainty may be offset by a variety of risk mitigation measures which can ensure appropriate patient and research participant protections in investigational research settings. “For proposed IDE studies, at earlier stages of device development, FDA considers appropriate mitigation measures for anticipated possible risks and unanticipated risks, whereas in later stages, FDA considers whether risk mitigation measures focus on the most probable risks,” it says.